Rolling Out of Tenofovir Gel in Family Planning Clinics: The CAPRISA 008 Implementation Trial

Abstract

Product effectiveness in ``real-world'' settings in healthcare services may differ markedly from product efficacy observed in clinical trials. Limited data exists, beyond clinical trial settings, to guide the introduction of pre-exposure prophylaxis (PrEP) in healthcare services. Since a large number of young women utilise existing family planning (FP) services at primary healthcare clinics, these facilities present one of the best opportunities for introducing PrEP as a new HIV prevention technology for women as part of their well-established sexual and reproductive health services. CAPRISA 008 was a two-arm, open-label, randomised controlled, non-inferiority implementation trial, which provided participants from CAPRISA 004 with post-trial access to tenofovir gel while generating evidence that could be used for future implementation of topical PrEP (tenofovir gel) in women. Women were randomly assigned to receive tenofovir gel at clinical trial clinics or at FP clinics utilising Quality Improvement (QI) methodology to promote reliable service delivery. Higher adherence in FP clinics met the pre-defined non-inferiority criteria, demonstrating that integration of topical PrEP into FP services for African women is feasible, acceptable and achieves adherence equivalent to a clinical trial setting, providing evidence for PrEP scale-up using this strategy for this challenging high-priority population.